NCT03689842 Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)
| NCT ID | NCT03689842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hopital Foch |
| Condition | Mayer Rokitansky Kuster Hauser Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2017-12-14 |
| Primary Completion | 2027-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2017-12-14 with a primary completion date of 2027-12-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In France, one in 4500 women is affected by the MayerRokitantskyKüsterHauser (MRKH) syndrome which is characterized by the absence of uterus at birth. Currently, the only solutions for these patients are: * Gestational surrogacy, prohibited in France * Adoption * Resignation Uterine transplantation could become a good alternative. This study is conducted in 10 patients with MRKH type I syndrome, who will be transplanted from a living donor uterus
Eligibility Criteria
Inclusion Criteria: Graft recipient is a patient with Mayer-Rokitansky-Küster-Hauser Type I Uterine Vaginal Agenesis (without renal, cardiac and bone malformations): * Being aged between 18 and 38 years old * In stable couple, with a pregnancy project, favorable psychological evaluation * No history of cancer and transfusion The living donor is a woman related to the Graft recipient with * Absence of comorbidity (neurological, nephro-urological pathology, infectious, psychiatric or psychological pathology) * Absence of uterine surgery, abdomino-pelvic major pathology history Exclusion Criteria: Graft recipient: * Extreme oligo-astheno-spermia and azoospermia in the husband * History of abdominopelvic surgery excluding uncomplicated appendectomy; vaginal residue not allowing anastomosis Living donor : * Known thromboembolic risk factor * No Compatibility with the recipient (group, rhesus, HLA)
Frequently Asked Questions
Who can join the NCT03689842 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Mayer Rokitansky Kuster Hauser Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03689842 currently recruiting?
Yes, NCT03689842 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hopital Foch to inquire about joining.
Where is the NCT03689842 trial being conducted?
This trial is being conducted at Suresnes, France.
Who is sponsoring the NCT03689842 clinical trial?
NCT03689842 is sponsored by Hopital Foch. The trial plans to enroll 20 participants.